Lifestyle Changes for Pancreatic Cancer Risk Reduction

(PANTHER-PIC Trial)

Overseen By Jennifer Permuth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: High grade dysplasia, Unstable cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for reducing pancreatic cancer risk?

Research suggests that physical activity and lifestyle changes can help reduce the risk of pancreatic cancer by lowering body weight, improving insulin sensitivity (how well the body uses insulin), and decreasing inflammation. Studies have shown that consistent physical activity over time may slightly lower the risk of developing pancreatic cancer. ^{1 2 3 4 5}

Is it safe for humans to participate in lifestyle changes like diet and exercise for reducing pancreatic cancer risk?

Research on diet and exercise interventions in pancreatic cancer patients shows that these lifestyle changes are generally safe, with studies focusing on adherence and adverse events during exercise programs. While the studies vary in design and outcomes, they do not report significant safety concerns for humans. ^{2 5 6 7 8}

How does the treatment of lifestyle changes for pancreatic cancer risk reduction differ from other treatments?

This treatment focuses on modifying lifestyle factors like diet and physical activity to reduce the risk of pancreatic cancer, unlike traditional treatments such as surgery or chemotherapy, which are used after the disease has developed. By addressing modifiable risk factors like obesity and physical inactivity, this approach aims to prevent the disease before it starts. ^{1 2 9 10 11}

What is the purpose of this trial?

The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.

Research Team

Shaffer Mok, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals at risk of pancreatic cancer, specifically PDAC. It's designed to see if lifestyle changes like increased physical activity and improved nutrition can help reduce their risk. Details on who exactly can join are not provided, but typically participants would need to meet certain health criteria.

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to 25 kg/m2

I am able to get out of my bed or chair and move around.

My pancreatic growth is confirmed and larger than 15 mm.

Exclusion Criteria

Screen failure for exercise safety

My condition involves high-risk pancreatic cysts or cancer.

I do not have unstable heart or lung conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

Participants engage in a lifestyle intervention involving 150 minutes/week of moderate to vigorous physical activity and nutritional counseling following a Mediterranean diet.

24 weeks

Regular self-monitoring and counseling appointments

Follow-up

Participants are monitored for retention, adherence, and acceptability of lifestyle modifications.

4 weeks

Treatment Details

Interventions

• Nutrition
• Physical Activity

Trial Overview The study is testing whether a combination of regular physical activity (PA) and nutritional guidance (N) can positively impact the health outcomes of those at elevated risk for pancreatic ductal adenocarcinoma (PDAC).

Participant Groups

Group I: Physical Activity (PA) and Nutrition (N) Experimental Treatment 2 Interventions

Physical Activity: Participants will perform 150 minutes/week of moderate to vigorous Physical Activity per week. Participants will self-monitor physical activity using "active minutes" that approximate moderate to vigorous physical activity via a Fitbit device. Nutrition: Participants will undergo counseling appointments to address nutritional symptoms and will be given targets for daily calorie and protein intake following a Mediterranean diet.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Miles for Moffitt

Collaborator

Trials

1

Recruited

20+

Findings from Research

An updated meta-analysis of 30 studies involving 10,501 pancreatic cancer cases found a weak but statistically significant reduction in pancreatic cancer risk associated with high levels of physical activity, with a relative risk of 0.93.

The analysis suggested that consistent physical activity over time may offer a greater protective effect against pancreatic cancer (RR 0.86) compared to recent or distant past activity, although the overall association remains weak and is not influenced by smoking status or body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis. Behrens, G., Jochem, C., Schmid, D., et al.[2022]

Increased physical activity (PA) significantly reduced systemic inflammatory cytokines in overweight and obese individuals, suggesting a potential mechanism for preventing obesity-related pancreatic ductal adenocarcinoma (PDAC).

In pre-clinical models, PA combined with dietary changes delayed weight gain and reduced PDAC incidence, indicating that lifestyle interventions may help prevent PDAC in high-risk obese individuals, although weight loss alone did not prevent tumor growth in certain models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation. Pita-Grisanti, V., Dubay, K., Lahooti, A., et al.[2023]

A 12-week multimodal lifestyle intervention for a 55-year-old woman with advanced pancreatic cancer was found to be safe and feasible, showing significant improvements in body weight and physical fitness.

The intervention also led to reductions in psychological distress, anxiety, and depression, suggesting that integrated supportive care can effectively manage symptoms of metastatic cancer and cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report. Avancini, A., Trestini, I., Tregnago, D., et al.[2023]

Exercise is feasible and can improve physical fitness and quality of life in patients undergoing treatment for pancreatic cancer, based on a review of 24 clinical trials.

However, the benefits of exercise may decrease as the disease progresses, indicating a need for more rigorous research to establish effective exercise protocols tailored for pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. Gupta, P., Hodgman, CF., Schadler, KL., et al.[2023]

A systematic review of 28 studies found that higher levels of total physical activity and occupational activity are associated with a reduced risk of pancreatic cancer, with relative risks of 0.72 and 0.75, respectively.

Moderate physical activity may offer more protection against pancreatic cancer compared to vigorous activity, although the results were not statistically significant, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can physical activity modulate pancreatic cancer risk? a systematic review and meta-analysis. O'Rorke, MA., Cantwell, MM., Cardwell, CR., et al.[2018]

In a case-control study of 186 pancreatic cancer cases and 554 controls, light and moderate physical activity were associated with a reduced risk of pancreatic cancer, highlighting the importance of maintaining an active lifestyle.

Dietary factors also played a significant role, with higher intakes of saturated and polyunsaturated fats increasing cancer risk, while higher fiber intake was linked to a reduced risk, suggesting that lifestyle choices can influence insulin resistance and pancreatic cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, diet, and pancreatic cancer: a population-based, case-control study in Minnesota. Zhang, J., Dhakal, IB., Gross, MD., et al.[2022]

A scoping review of 15,708 articles identified only 62 relevant studies on diet and exercise interventions for patients with pancreatic cancer, highlighting a significant gap in research on this topic.

Most studies focused on dietary interventions, particularly omega-3 fatty acids, while only a small number examined exercise, indicating a need for more comprehensive research to understand how these interventions can help combat malnutrition and muscle wasting in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. Kasvis, P., Kilgour, RD.[2022]

A 12-week supervised exercise program for 22 patients with pancreatic cancer showed significant improvements in functional ability, muscle strength, and balance, with no serious adverse events reported, indicating that exercise is safe during nonsurgical treatment.

Patients who continued exercising beyond the initial 12 weeks maintained their physical improvements, suggesting that ongoing exercise may be beneficial for preserving health in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. Luo, H., Galvão, DA., Newton, RU., et al.[2023]

Pancreatic cancer is a highly lethal disease with increasing incidence, often diagnosed too late for effective treatment due to a lack of early detection biomarkers.

Modifiable lifestyle factors, such as high alcohol and processed meat consumption, obesity, diabetes, and smoking, significantly increase the risk of developing pancreatic cancer, suggesting that addressing these factors could help prevent many new cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of lifestyle and environment risk factors for pancreatic cancer. Zanini, S., Renzi, S., Limongi, AR., et al.[2021]

The systematic review of 4 prospective studies found no significant overall association between total physical activity and pancreatic cancer risk, with a summary relative risk of 0.76, indicating that higher physical activity levels do not strongly correlate with lower pancreatic cancer risk.

However, there was a notable decrease in pancreatic cancer risk associated with occupational physical activity (relative risk of 0.75), while leisure-time physical activity showed no significant effect (relative risk of 0.94), suggesting that the type of physical activity may influence cancer risk differently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and pancreatic cancer risk: a systematic review. Bao, Y., Michaud, DS.[2018]

Obesity significantly increases the risk of pancreatic cancer, with individuals having a body mass index (BMI) of 30 or higher showing more than double the risk compared to those with a normal BMI (RR 2.08).

Central weight gain is also linked to a higher risk of pancreatic cancer, with individuals reporting central adiposity having a 45% increased risk compared to those with peripheral weight gain (RR 1.45).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity, recreational physical activity, and risk of pancreatic cancer in a large U.S. Cohort. Patel, AV., Rodriguez, C., Bernstein, L., et al.[2005]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity and risk of pancreatic cancer: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Delays Obesity-Associated Pancreatic Ductal Adenocarcinoma in Mice and Decreases Inflammation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary lifestyle intervention to manage pancreatic cancer-related cachexia: a case report. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effect of exercise on pancreatic cancer patients during treatment: a scoping review of the literature. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Can physical activity modulate pancreatic cancer risk? a systematic review and meta-analysis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Physical activity, diet, and pancreatic cancer: a population-based, case-control study in Minnesota. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Clinic-Based Exercise Program in Patients with Pancreatic Cancer Undergoing Nonsurgical Treatment. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A review of lifestyle and environment risk factors for pancreatic cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Physical activity and pancreatic cancer risk: a systematic review. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Obesity, recreational physical activity, and risk of pancreatic cancer in a large U.S. Cohort. [2005]